Gilead strikes cancer drug deal

By Stephanie M. Lee

Published 4:11 pm, Friday, December 19, 2014

After a successful year entering the market for hepatitis C therapies, Gilead Sciences is expanding into cancer.

The Foster City company said late Thursday that it had entered into an exclusive license agreement with Ono Pharmaceutical Co. to develop and market a potential therapy for B-cell malignancies, or blood cancers.

Under the deal, whose terms were not disclosed, Gilead will pay Ono an initial sum, plus additional payments based upon milestones. Both companies will work on Ono’s candidate drug, known as Ono-4059, which has shown promising results against chronic lymphocytic leukemia and non-Hodgkin lymphoma in Phase I clinical trials.

Ono-4059 is a daily pill designed to inhibit an enzyme that plays a role in the survival and proliferation of malignant B-cells, and the companies want to develop it both as a drug that can be taken alone and in combination with other therapies.

Gilead will have exclusive rights to develop and sell the medication in all countries of the world outside of Japan, South Korea, Taiwan, China and other countries in Southeast Asia. Ono will have development and sales rights in those nations.

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Gilead took its first step into the cancer market this year with Zydelig, which won federal approval in July for three B-cell blood cancers: relapsed chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. And on Monday, the company hired Dr. Philippe Bishop away from Genentech, where he helped oversee oncology, to be its senior vice president of hematology and oncology therapeutics.

Expect to see more cancer deals from Gilead in 2015, said Michael Yee, a biotechnology analyst at RBC Capital Markets.

In an investors’ note, Yee noted that Ono’s drug is similar to Pharmacyclics’ blood cancer drug, Imbruvica, which has been approved for chronic lymphocytic leukemia in patients who have been previously treated or have a certain genetic anomaly, as well as for mantle cell lymphoma in previously treated patients. The Ono drug “has similarly high response rates and clean safety in Phase I,” Yee wrote, adding that the drug could be successful if combined with Zydelig.

The move by Gilead to make deals for cancer drugs “is smart, as it has resources and capabilities to go after a rapidly evolving and growing but important immuno-oncology field,” Yee wrote.

Gilead certainly has the budget to explore cancer therapies, thanks in large part to the runaway success of Sovaldi, its $1,000-a-day hepatitis C cure, and Harvoni, an even faster-working, next-generation version of Sovaldi.